Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma

Recruiting in Palo Alto (17 mi)

+75 other locations

Overseen byLars Wagner

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.

Research Team

Lars Wagner

Principal Investigator

Children's Oncology Group

Eligibility Criteria

Inclusion Criteria

Osteosarcoma

Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)

Rhabdomyosarcoma

See 7 more

Treatment Details

Interventions

Cixutumumab (Monoclonal Antibodies)
Temsirolimus (mTOR Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (cixutumumab, temsirolimus)Experimental Treatment3 Interventions

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.